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NF EN ISO 11737-2 : 2010

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
Withdrawn date

28-10-2021

Published date

12-01-2013

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Éléments du système de management de la qualité
5 Sélection du produit
6 Méthodes utilisées pour les controles de stérilité
7 Évaluation de la méthode des controles de stérilité
8 Maintenance de la méthode des controles de stérilité
Annexe A (informative) - Directives concernant les controles
         de stérilité pratiqués au moment de la validation et
         de la maintenance d'un procédé de stérilisation
Bibliographie

Establishes the general requirements for tests on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.

DevelopmentNote
Indice de classement: S98-118-2. Supersedes NFS 98 118. (03/2004) PR NF EN ISO 11737-2 February 2008. (02/2008)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Withdrawn
SupersededBy
Supersedes

NF EN ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment

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